Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619275
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Ripretinib QINLOCK According to Current SmPC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor GIST a Prospective Longitudinal Multicenter Observational Study in Germany
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTEREST
Brief Summary:
The goal of this prospective observational study INTEREST is to collect real-world data on ripretinib treatment in a broad patient population in Germany Ripretinib will be administered according to the current SmPC Thus INTEREST will evaluate for the first time ripretinib in GIST patients in a real-world setting in Germany
The main questions the study aims to answer are
Evaluate quality of live QoL using the questionnaire EQ-5D-5L to gain knowledge about how ripretinib treatment affects GIST patients well-being change compared to Baseline Time to Deterioration
Assessment of effectiveness in routine treatment Progression-Free Survival Overall Survival Best Response Overall Response Rate Disease Control Rate
Assessment of drug safety
Assessment of parameters of physicians39 treatment decision making
Description of treatment reality in detail
The main questions the study aims to answer are
Evaluate quality of live QoL using the questionnaire EQ-5D-5L to gain knowledge about how ripretinib treatment affects GIST patients well-being change compared to Baseline Time to Deterioration
Assessment of effectiveness in routine treatment Progression-Free Survival Overall Survival Best Response Overall Response Rate Disease Control Rate
Assessment of drug safety
Assessment of parameters of physicians39 treatment decision making
Description of treatment reality in detail
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: